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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, nephrostomy
510(k) Number K990689
Device Name ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
Applicant
ZCV ,INC.
298 FERNWOOD AVE.
EDISON,  NJ  08837
Applicant Contact PRISCILLA WHITEHEAD COX
Correspondent
ZCV ,INC.
298 FERNWOOD AVE.
EDISON,  NJ  08837
Correspondent Contact PRISCILLA WHITEHEAD COX
Classification Product Code
LJE  
Date Received03/03/1999
Decision Date 09/03/1999
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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